In the global lubricating jelly market, Europe, America, and Japan have always been strategic high grounds competed for by major brands due to their large market size, high consumer maturity, and well-established regulatory systems.
However, to successfully enter these mainstream markets, one must first cross their stringent "entry thresholds"-obtaining qualification certifications from local authoritative institutions. If a lubricating jelly custom manufacturing enterprise has fully unlocked market access to major markets like Europe, America, and Japan, what qualification advantages does this entail, and what core values can it bring to partner brands?
For the US market, there's FDA certification, especially the 510(k) premarket notification for medical device classification. Obtaining this approval means the product's safety, effectiveness, and substantial equivalence to already marketed products have been recognized by the US Food and Drug Administration, serving as the "golden key" for legal sales in the US.
For the 27 EU member states and some other European countries, there's the CE mark. The CE mark indicates that the product complies with a series of relevant EU directives on health, safety, and environmental protection. Possessing CE certification allows products to circulate freely within the European Economic Area, making it an essential "passport" for tapping into the European market.
For the Japanese market, although it has its independent PMDA (Pharmaceuticals and Medical Devices Agency) regulatory system, it typically references internationally common standards like ISO 13485 (Medical device quality management systems-Requirements for regulatory purposes). If a factory can pass ISO 13485 certification and is familiar with the special requirements of the Japanese market, it will lay a solid foundation for its products to enter Japan.
When a custom enterprise, such as PINGCHUANG MEDICAL, can simultaneously possess FDA 510K, CE certification, and operate in strict accordance with the ISO 13485 system, it's more than just a few certificates. It represents that the enterprise has reached internationally leading levels in multiple dimensions, including R&D capabilities, production processes, quality control, risk management, and regulatory compliance.
PINGCHUANG MEDICAL, by virtue of its global market access qualifications built upon its Class II Medical Device Registration Certificate for medical lubricants, ISO 13485, US FDA 510K, and EU CE certifications, has fully unlocked the pathways to mainstream markets like Europe, America, and Japan for its partner brands.
